N/A
N=53
Discontinuation of Orthokeratology on Eyeball Elongation in Myopic Children
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01236742 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Change in Axial Length — 0.153; 0.087; 0.082; 0.059 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ortho-k lenses (Device); single-vision glasses (Device)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- The Hong Kong Polytechnic University
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Axial Length |
0.153; 0.087; 0.082; 0.059; 0.068; 0.064 | — |
| SECONDARY Incidence of Adverse Effects |
0; 0; 0; 1; 0; 0 | — |
Summary
The primary aim of this study is to compare eyeball elongation in existing ortho-k subjects who stop the treatment with subjects who continue ortho-k lens wear and control subjects wearing single-vision glasses.
Eligibility Criteria
Inclusion Criteria
- Age 8-14 years old (inclusive)
- Subjects who have completed the ROMIO, TO-SEE or HM-PRO studies at The Hong Kong Polytechnic University
- Willingness to be randomized into groups (for ortho-k subjects)
- Availability for follow-up for at least 14 months
Exclusion Criteria
- Non-compliance to the follow up schedule
- Non-compliance to the assigned optical correction (i.e. single-vision glasses or ortho-k lenses)
- Contraindication for contact lens wear and ortho-k (e.g. limbus to limbus corneal cylinder and dislocated corneal apex)
- Systemic or ocular) conditions which may affect contact lens wear (e.g. allergy and medication)
- Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)
Data sourced from ClinicalTrials.gov (NCT01236742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.